Mechanism-based cancer risk assessment of butylated hydroxyanisole

The evidence for BHA-induced carcinogenicity is restricted to the rodent non-glandular stomach, which is not found in humans. Although an argument can be made that an effect in this target organ could be indicative of potential carcinogenicity in other tissues, particularly the esophagus, studies have not revealed such a correlation. BHA-induced proliferative effects, which appear to be critical for the tumorigenic response, show a NOEL at a dose below that yielding benign tumors. The NOEL of this BHA-induced proliferative effect demonstrates a substantial margin of safety compared to human intake of BHA. Thus based on both dose-response considerations and the species-specific response, the use of BHA as a food additive does not pose a carcinogenic risk in humans.